Description

LPP-100: GMP Automatic High-Yield Dosing System for Sterile Powders with Dual Combined Screw Drives

Unprecedented Reliability for Critical Sterile Manufacturing

In sterile pharmaceutical production, unexpected downtime is not an option. The LPP-100’s revolutionary dual-head architecture is your ultimate insurance policy. This redundant design ensures that your high-value batch continues to run even during a dosing head adjustment or cleaning cycle, protecting you from catastrophic production stoppages and ensuring you meet your most demanding delivery schedules.

The Gold Standard in Aseptic Powder Handling

This system is more than a doser; it’s an integrated containment and quality assurance system.

• Zero Contamination Risk: The sealed, clean-in-place (CIP) capable design eliminates manual intervention, maintaining the sterility of the product from the bulk container to the final primary packaging.

• Unmatched Accuracy for Potent Drugs: The combined screw technology in each head guarantees precise dosing of high-potency APIs, where even a milligram deviation is unacceptable.

• Complete Regulatory Readiness: The machine is delivered with the documentation and design features (materials certificates, surface finish reports, IQ/OQ protocol support) to streamline your validation process.

Technical Specifications at a Glance

• Dosing Principle: Dual Combined (Macro/Micro) Screw, Gravimetric Feedback

• Compliance: cGMP, GAMP 5, supports FDA 21 CFR Part 11

• Containment Level: Hermetically Sealed (OEB4/OEB5 capable)

• Construction: 316L Stainless Steel, CIP/SIP capable

• Control System: Industrial PLC with Touch Screen HMI and Data Historian

Ideal for the Most Demanding Sterile Applications

• Lyophilized (Freeze-Dried) Product Filling: Precise dosing of powders for sterile injectables.

• High-Potency API (HPAPI) Manufacturing: Safe and accurate handling of potent and cytotoxic compounds.

• Aseptic Powder Fill/Finish: For vials, syringes, and cartridges in biopharma and vaccine production.

Key Features.

Dual-Head Redundant Dosing System: Two fully independent combined screw dosing units operate in parallel, allowing for continuous production. If one head requires maintenance, the other can continue operation, ensuring 100% production line uptime.

Full cGMP & Aseptic Design: Constructed with 316L stainless steel, electropolished welds, and sanitary finishes. Designed for easy sterilization (CIP/SIP) and validation, meeting the strictest regulatory standards for sterile drug production.

Advanced Combined Screw Technology: Each head utilizes a hybrid macro/micro screw system. The primary screw handles high-speed bulk feeding, while the secondary precision screw delivers the final, accurate dose, achieving gravimetric-level accuracy for even the most challenging powders.

High-Containment for Potent Compounds: A fully hermetic design prevents the escape of potent or hazardous sterile powders, protecting operators and the environment (capable of handling OEB4/OEB5 compounds).

Data Integrity & Traceability: Integrated control system with comprehensive data logging, electronic batch records, and user access controls to support compliance with FDA 21 CFR Part 11 and EU Annex 11.

High-Yield Performance: Engineered for maximum throughput without sacrificing the precision and sterility required for vial, syringe, or other critical container filling lines.

📜 Schedule virtual airflow visualization test.

💡 Mention your: Target market (EU/US/Global South), Active ingredient, Required throughput.

🔬 Schedule virtual factory acceptance test with our engineers.

🏷️ Request Compliance Audit: Free gap analysis with throughput simulation.

🔍Ready to Eliminate Production Bottlenecks?

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📥Free line configuration for your products, throughput validation testing!